The medication was sold in 0.5 ounce and 1-ounce bottles to reduce fever and pain under the Equate, CVS Health and Family Wellness brands at Walmart, CVS and Family Dollar stores, respectively. Additional details on lot numbers and expiration dates are available at https://www.fda.gov/Safety/Recalls/ucm630112.htm.

No adverse events have been reported to Tris Pharma Inc., but ibuprofen concentrations have been found as high as 10% above the specified limit, according to the company. The higher potency could cause nausea, vomiting, diarrhea, tinnitus, headache and gastrointestinal bleeding, according to the company. Infants may be more vulnerable to permanent kidney damage.